Regulatory Strategy Lead, US & Canada

Regulatory Jobs

Irvine (CA)

On-site

USD 170,000 - 210,000

Full time

6 days ago

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Job summary

AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead in Irvine to drive regulatory strategy for on-market and development programs. You will collaborate with cross-functional teams to develop, implement and maintain regulatory plans, and interface with FDA and Health Authorities to support submissions and inquiries.

The role emphasizes strategic thinking, strong negotiation skills, and experience navigating Complex regulatory environments across US and Canada, with a

Qualifications

Minimum 5 years regulatory, R&D, or equivalent industry-related experience.
Demonstrates excellent negotiation skills and builds consensus.
Experience interfacing with government regulatory agencies.

Responsibilities

Develops and implements US and Canada regulatory strategy and tactical planning.
Acts as Health Authority liaison and coordinates FDA meetings and briefing packages.
Advises internal customers on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal and Commercial.
Prepares and reviews regulatory submissions to meet US/Canada requirements.
Ensures timely responses to Health Authorities during application reviews.
Supports regulatory submission and approval processes across therapeutic areas.
Presents regulatory information to cross-functional teams.

Skills

Negotiation skills

Problem solving

Communication skills

Regulatory strategy

Cross-functional collaboration

Education

Advanced degree (PharmD, PhD, MS)

Job description

The role emphasizes strategic thinking, strong negotiation skills, and experience navigating Complex regulatory environments across US and Canada, with a

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